Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of INCB160058 When Administered Orally to Healthy Adult Participant
Lead Sponsor:
Incyte Corporation
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 When Administered Orally to Healthy Adult Participants.
Eligibility Criteria
Inclusion
- Ability to comprehend and willingness to sign a written ICF for the study.
- Age 18 to 55 years, inclusive, at the time of signing the ICF.
- Body mass index between 18.0 and 32.0 kg/m2 (inclusive).
- Willingness to adhere to study-related prohibitions, restrictions, and procedures.
- Ability to swallow and retain oral medication.
- Willingness to avoid pregnancy or fathering children based on the criteria below.
- Male participants with reproductive potential must agree to use 1 of the highly effective methods of contraception to avoid fathering children from screening through the last follow-up visit and must refrain from donating sperm during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed.
- Female participants who are WOCBP must have a negative pregnancy test at screening and check-in, must agree to use 1 of the highly effective methods of contraception to avoid pregnancy from screening through the last follow-up visit, and must refrain from donating oocytes during this period.
- Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed. Positive pregnancy tests may be confirmed at the investigator's discretion.
- • Female participants not considered to be of childbearing potential are eligible and must have a negative pregnancy test at screening and check-in.
Exclusion
- History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
- History of rheumatologic/autoimmune disorders and immune deficiency/immunologic defects.
- Prior history of major bleeding or thrombosis, including myocardial infarction/stroke and pulmonary embolism/deep vein thrombosis.
- Known tuberculosis infection that is active or participant-reported history of tuberculosis or treatment thereof.
- Resting pulse \< 40 bpm or \> 100 bpm, confirmed by repeat testing at screening.
- History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant (QTcF interval \> 450 milliseconds, QRS interval \> 120 milliseconds, and PR interval \> 220 milliseconds).
- Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis).
- Hemoglobin level, WBC count, platelet count, or absolute neutrophil count below the laboratory lower limit of normal at screening or at check-in, confirmed by repeat testing and clinically significant in the opinion of the investigator.
- Hepatic transaminase (ALT and AST), ALP, or total bilirubin levels \> 1.25 × the laboratory-defined ULN at screening or at check-in, confirmed by repeat testing (except participants with Gilbert disease, for which total bilirubin must be ≤ 2.0 × ULN).
- History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ, or prostate cancer.
- Current or recent (within 3 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy) that could affect the absorption of study drug, with the exception of appendectomy.
- Any major surgery within 12 weeks of screening.
- Donation of blood to a blood bank within 4 weeks of screening (within 2 weeks for plasma only).
- Blood transfusion within 4 weeks of check-in.
- Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
- Positive test for hepatitis B virus, hepatitis C virus, or human immunodeficiency virus.
- Note: Participants whose results are compatible with prior immunization or immunity due to infection for hepatitis B may be included at the discretion of the investigator.
- Regular alcohol consumption \> 21 units per week (1 unit = ½ pint beer or a 25-mL shot of 40% spirit, 1.5 to 2 units = 125-mL glass of wine, depending on type).
- Positive urine or breath test for ethanol or positive urine or serum screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.
- Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with another investigational medication or current enrollment in another investigational drug protocol.
- Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug with an inducer or inhibitor of CYP3A4, P-gp, or BCRP (refer to the Drug Interaction Database for prohibited drugs).
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
- Known hypersensitivity or severe reaction to INCB160058 or any excipients of INCB160058 (refer to the IB).
- Inability to undergo venipuncture or tolerate venous access.
- Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
- Use of tobacco- or nicotine-containing products within 1 month of screening.
- Use of prescription drugs (including oral, implantable, transdermal, injectable, intravaginal, or hormonal intrauterine contraceptives) or topical steroids within 14 days prior to study drug administration or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic, herbal, or plant-derived preparations) within 7 days prior to study drug administration and during the study.
- Note: Occasional use of acetaminophen (see Section 6.6.1) is permitted during the study.
- Women who are pregnant or breastfeeding.
- eGFR \< 90 mL/min/1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration formula.
- Any history of hypersensitivity or intolerance to esomeprazole or any other PPI, or to famotidine or any other H2 antagonist.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Key Trial Info
Start Date :
March 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2025
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT06213818
Start Date
March 14 2024
End Date
August 19 2025
Last Update
October 14 2025
Active Locations (1)
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1
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia, 03004